Health Condition 1: null- Pregnant women beyond 20 weeks gestation or during intrapartum period detected to have a systolic BP more than equal to 160 mm Hg or diastolic BP more than equal to 110 mm Hg will be recruited.
Conditions
Interventions
Intervention1: Antihypertensives: Same as comparator group
Control Intervention1: Intravenous Labetalol, Intravenous Hydralazine and oral Nifedipine: Intravenous Labetalol would be given in recommende
Sponsors
University College of Medical Sciences and associated Guru Teg Bahadur Hospital
BHARAT SERUMS AND VACCINES Limited
Cadila Healthcare limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pregnant women beyond 20 weeks gestation or during intrapartum period detected to have a systolic BP more than equal to 160 mm Hg or diastolic BPmore than equal to 110 mmHg will be recruited. These patients could be a. Cases of gestational hypertension with no previous antihypertensive therapy. b. Cases of gestational hypertension with previous antihypertensive therapy other than Labetalol, Hydralazine or Nifedipine c. Cases of gestational hypertension with superimposed pre-eclampsia d. Cases of severe preeclampsia, HELLP syndrome with systolic BP ï?³160 mm Hg and/or diastolic BP >=110 mmHg. 2. Women willing to participate in the study with informed written consent.
Exclusion criteria
Exclusion criteria: 1. Eclampsia 2. Cases presenting with pulmonary edema 3. Cases of severe hypertension in pregnancy with impaired state of consciousness or altered sensorium 4. Women with history of heart disease, asthma, renal disease 5. Intake of any of the drugs being studied, in preceding 72 hours 6. Women presenting with history of allergy to any of the drugs being studied or developing adverse effects requiring discontinuation of therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the time taken between i.v.Labetalol,i.v.Hydralazine or oral Nifedipine to achieve the therapeutic goal of lowering systolic blood pressure to less than 150 mm Hg and diastolic blood pressure to less than 100 mm Hg.Timepoint: 20min,40min,60min,80min,100min | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the maternal adverse effects of the three drugs.Timepoint: 120 miutes;To compare the total dose of i.v. Labetalol,i.v.Hydralazine or oral Nifedipine required to achieve the therapeutic goal of lowering systolic blood pressure to less than 150 mm Hg and diastolic blood pressure to less than 100 mmHgTimepoint: 120 minutes;To compare the incidence of intrapartum fetal distress between the three groups in patients undergoing termination of pregnancy within 24 hrs. of induction into the study.Timepoint: 24 hours | — |
Countries
India
Contacts
Public ContactDr Gita Radhakrishan
University College of Medical Sciences
Outcome results
None listed